HER2 Low Breast CarcinomaNCT05754047
Tumor Characteristics and Survival Rate of HER2-Low Breast Cancer Patients
An observational study of HER2 Low Breast Carcinoma, run by Mahdis Bayat.
Trial summary
In this large-scale cross-sectional study, we evaluated disease-free survival (DFS), overall survival (OS), and clinicopathological characteristics of BC patients from 1991 to 2022, retrospectively. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- HER2 Low Breast Carcinoma
- What is being tested?
- immunohistochemistry (IHC) and in situ hybridization (ISH) Test
- How many people
- 3,582 participants
- Where
- No sites listed yet
- Study dates
- Apr 1991to Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: There were 3918 patients with human epidermal growth factor receptor 2 (HER2) status in the database of the Cancer Research Center (CRC), among which, 24 male patients and 312 patients with missing DFS and OS information were excluded. In total, 3582 patients have been included in DFS and OS analysis.
Who may be able to join
- All breast cancer patients with human epidermal growth factor receptor 2 (HER2) status in the database of the Cancer Research Center (CRC),from April 1991 to March 2022
Who cannot join
- The male gender Patients with indeterminate or missing HER2 status, or patients with missing DFS and OS information
About this study
Official title: Tumor Characteristics and Survival Rate of HER2-Low Breast Cancer Patients; a Cross-Sectional Study
In this large-scale cross-sectional study, we evaluated disease-free survival (DFS), overall survival (OS), and clinicopathological characteristics of BC patients from 1991 to 2022, retrospectively. We recruited patients referred to the Cancer Research Center in Tehran, Iran, and their HER2 status, which is classified as HER2-low, HER2-positive, or HER2-negative, was obtained from prospectively maintained registries. we aimed to dive more deeply into the clinicopathological characteristics and survival features of HER2-low breast cancer patients and campared it with HER2-negative and HER2-positive groups.
Question 1: Is HER2-low breast cancer (BC) a new subtype in the standard classification of BCs? Question 2: How is the DFS and OS rate of HER2-low breast cancer patients in comparison with HER2-negative and HER2-positive groups?
- Conditions
- HER2 Low Breast Carcinoma
- Being tested
- immunohistochemistry (IHC) and in situ hybridization (ISH) Test
- Keywords
- Breast cancer, ErbB-2, HER2-low, Disease-Free Survival, Survival Rate
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunohistochemistry (IHC) and in situ hybridization (ISH) TestDiagnostic test
These tests are usually applied for breast cancer patients to assist the surgeon to better understand the clinicopathological characteristics and survival features of tumors
| Study group | Role | What they receive |
|---|---|---|
| HER2-low | patients with HER2 IHC1+ and HER2 IHC2+/ISH-negative in their pathology Receives: Diagnostic Test: immunohistochemistry (IHC) and in situ hybridization (ISH) Test | |
| HER2-negative | patients with HER2-zero in their pathology Receives: Diagnostic Test: immunohistochemistry (IHC) and in situ hybridization (ISH) Test | |
| HER2-positive | patients with HER2 IHC2+/ISH-positive and HER2 IHC 3+ in their pathology Receives: Diagnostic Test: immunohistochemistry (IHC) and in situ hybridization (ISH) Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
HER2-low OS
HER2-low status had the highest survival rate.
Measured: 38 months
HER2-low DFS
HER2-low status had the highest DFS.
Measured: 33 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study startApr 1991
- Primary completionMar 2022
- Study completionMar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HER2 Low Breast CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 3,582 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahdis Bayat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mahdis Bayat, Shahid Beheshti University of Medical Sciences
- Investigators
- Mohammad Esmail Akbari, Professor, Study director, Cancer Research Center, Shohadaye Tajrish Hospital, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754047
- Sponsor's protocol ID
- MBAYAT
- Status last verified
- Mar 2023
- First submitted
- 22 Feb 2023
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon a reasonable request. Due to the sensitive nature of the clinical data collected in this study, patients were assured raw data would remain confidential and would not be shared except under specific requests.
Publications
Abbasvandi F, Bayat M, Akbari A, Shojaeian F, Zandi A, Rahmani J, Hashemi MO, Akbari ME. Tumor characteristics and survival rate of HER2-low breast cancer patients: a retrospective cohort study. Sci Rep. 2023 Oct 4;13(1):16719. doi: 10.1038/s41598-023-43186-8.
PubMed 37794050
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor Characteristics and Survival Rate of HER2-Low Breast Cancer Patients; a Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT05754047
- Acronym / sponsor ID
- MBAYAT
- Conditions
- HER2 Low Breast Carcinoma
- Keywords
- Breast cancer, ErbB-2, HER2-low, Disease-Free Survival, Survival Rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,582 participants (actual)
- Lead sponsor
- Mahdis BayatUniversity, hospital or other
- Study start
- Apr 1991 (actual)
- Primary completion
- Mar 2022 (actual)
- Study completion
- Mar 2022 (actual)
- First posted
- 3 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this large-scale cross-sectional study, we evaluated disease-free survival (DFS), overall survival (OS), and clinicopathological characteristics of BC patients from 1991 to 2022, retrospectively. We recruited patients referred to the Cancer Research Center in Tehran, Iran, and their HER2 status, which is classified as HER2-low, HER2-positive, or HER2-negative, was obtained from prospectively maintained registries. we aimed to dive more deeply into the clinicopathological characteristics and survival features of HER2-low breast cancer patients and campared it with HER2-negative and HER2-positive groups.
Question 1: Is HER2-low breast cancer (BC) a new subtype in the standard classification of BCs? Question 2: How is the DFS and OS rate of HER2-low breast cancer patients in comparison with HER2-negative and HER2-positive groups?
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HER2-low | – | Diagnostic Test: immunohistochemistry (IHC) and in situ hybridization (ISH) Testpatients with HER2 IHC1+ and HER2 IHC2+/ISH-negative in their pathology |
| HER2-negative | – | Diagnostic Test: immunohistochemistry (IHC) and in situ hybridization (ISH) Testpatients with HER2-zero in their pathology |
| HER2-positive | – | Diagnostic Test: immunohistochemistry (IHC) and in situ hybridization (ISH) Testpatients with HER2 IHC2+/ISH-positive and HER2 IHC 3+ in their pathology |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- There were 3918 patients with human epidermal growth factor receptor 2 (HER2) status in the database of the Cancer Research Center (CRC), among which, 24 male patients and 312 patients with missing DFS and OS information were excluded. In total, 3582 patients have been included in DFS and OS analysis.
Key inclusion criteria (1 listed)
- All breast cancer patients with human epidermal growth factor receptor 2 (HER2) status in the database of the Cancer Research Center (CRC),from April 1991 to March 2022
Key exclusion criteria (1 listed)
- The male gender Patients with indeterminate or missing HER2 status, or patients with missing DFS and OS information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immunohistochemistry (IHC) and in situ hybridization (ISH) TestThese tests are usually applied for breast cancer patients to assist the surgeon to better understand the clinicopathological characteristics and survival features of tumors | Diagnostic test | HER2-low, HER2-negative, HER2-positive |
Primary outcome
HER2-low OS
Time frame: 38 months
HER2-low status had the highest survival rate.
HER2-low DFS
Time frame: 33 months
HER2-low status had the highest DFS.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Derived from this study: PubMed 37794050Abbasvandi F, Bayat M, Akbari A, Shojaeian F, Zandi A, Rahmani J, Hashemi MO, Akbari ME. Tumor characteristics and survival rate of HER2-low breast cancer patients: a retrospective cohort study. Sci Rep. 2023 Oct 4;13(1):16719. doi: 10.1038/s41598-023-43186-8.
- Individual participant dataSharing planned: No. Data will be available upon a reasonable request. Due to the sensitive nature of the clinical data collected in this study, patients were assured raw data would remain confidential and would not be shared except under specific requests.
Related trials for HER2 Low Breast Carcinoma
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RecruitingObservational study
Negative/Low Hormone Receptor And/or HER2 POsitive Lobular Invasive Breast Carcinoma - A Real-World International Cohort Study
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A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Esmail Akbari, Professor study director
Cancer Research Center, Shohadaye Tajrish Hospital, Shahid Beheshti University of Medical Sciences
Questions about this trial
What is this clinical trial studying?
An observational study of HER2 Low Breast Carcinoma, run by Mahdis Bayat.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HER2-low OS (time frame: 38 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05754047, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.